Advanced Endodontic System 90-2134E

GUDID 00850309007282

Advanced Endodontic System

ASI MEDICAL, INC.

Dental delivery system instrument unit, electric
Primary Device ID00850309007282
NIH Device Record Key51348b84-9fcd-4b8d-a4bc-5c7289e88407
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Endodontic System
Version Model Number90-2134E
Catalog Number90-2134E
Company DUNS808695159
Company NameASI MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850309007282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQYLocator, Root Apex

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-31

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00850309007367Advanced Endodontic System
00850309007343Advanced Endodontic System
00850309007329Advanced Endodontic System
00850309007305Advanced Endodontic System
00850309007282Advanced Endodontic System
00850309007268Advanced Endodontic System
00850309007244Advanced Endodontic System
00850309007220Advanced Endodontic System
00850309007206Advanced Endodontic System
00850309007183Advanced Endodontic System
00850309007169Advanced Endodontic System
00850309007145Advanced Endodontic System

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